Shock Wave Drug Balloon Catheter Device

Abstract

The present invention discloses a shock wave drug balloon catheter device, which comprises a drug balloon catheter assembly. The drug balloon catheter assembly includes a catheter body, an ultrasonic transducer, and a balloon component located at the distal end of the catheter body and connected to the catheter body. The balloon component has a balloon cavity, and the balloon cavity has a first filling state when partially filled and a second filling state when fully filled. When the balloon cavity is in the first filling state, it is used to fill a medium for shock wave treatment of vascular calcified plaques and for squeezing the calcified plaques. When the balloon cavity is in the second filling state, it is used to fill a medium for drug treatment of the blood vessel wall through the drug coated on the balloon cavity. The electrode end of the ultrasonic transducer extends into the balloon cavity, and the control end of the ultrasonic transducer is located at the proximal end of the catheter body. The shock wave drug balloon catheter device can effectively recover calcified substances, reduce thrombus formation, effectively inhibit tissue hyperplasia, and reduce complications such as vascular restenosis.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a shock wave drug balloon catheter device. Background Art

[0002] Vascular calcification refers to the pathophysiological process of abnormal deposition of minerals such as calcium and phosphorus in the blood vessel wall, which exists not only in diseases such as hypertension, atherosclerosis, and osteoporosis, but also in diseases such as diabetes, vascular lesions, and chronic kidney disease. With the advent of the era of social population aging, the incidence of calcification-related vascular diseases has also increased year by year. Vascular calcification is manifested as abnormal deposition of excessive calcium and phosphorus in the walls of large blood vessels such as coronary arteries and peripheral arteries, resulting in reduced arterial elasticity, lumen stenosis, increased vulnerability of atherosclerotic plaques, and induction of acute cardiovascular events. Vascular calcification seriously threatens the health of patients. In the United States, more than 9 million people are troubled by peripheral vascular diseases every year, and 30% - 50% of patients have varying degrees of calcification lesions in the blood vessel wall. When severe calcification occurs in lower limb peripheral blood vessels (such as femoral artery, anterior tibial artery, etc.), it will cause insufficient blood supply to the lower limbs, trigger pain in the patient's legs and affect normal walking. For patients with more serious conditions, surgical treatment or even amputation is required, bringing a heavy burden to patients and the medical system. Thus, the harm brought by cardiovascular system calcification cannot be underestimated, and how to better handle the calcification problem will further improve the treatment level of cardiovascular calcification diseases. The essence of vascular calcification is the transformation of vascular cell-like phenotypes into osteoblast-like phenotypes and the transformation of vascular tissue into bone tissue under various stimulating factors, and its formation is similar to the process of bone formation. Due to the disorder of the body's calcium and phosphorus metabolism regulation, calcium salts are passively deposited between cells and tissues, and this deposition is an uncontrollable degradation process.

[0003] At present, the main treatment methods for vascular calcification are medical treatment and surgical treatment. Medical treatment is to use lipid-lowering drugs to stabilize plaques in blood vessels and slow down the progression of atherosclerosis, or to regulate the overall calcium and phosphorus metabolism through calcium and phosphorus balance regulators such as phosphate binders and bisphosphonates to reduce calcium salt deposition and calcium crystal nucleation; however, the effects of these drugs on vascular calcification are not yet clear, and they have poor effects on patients in the late stage of vascular calcification. Surgical treatment methods include interventional treatment and arterial bypass grafting. In interventional treatment, the interventional devices include traditional balloons, special balloons, and percutaneous transluminal atherectomy. There are still many limitations in the equipment and technology required for interventional treatment, which are prone to cause serious complications. For example, traditional balloons have good dilation effects only on soft lesions. However, in the treatment of calcified lesion blood vessels, higher pressure is required to restore the lumen again. However, continuous high pressure is likely to cause secondary mechanical damage to blood vessels and even cause blood vessel rupture. Special balloons such as embedded and spiky balloons have special usage conditions and require operators to have undergone long-term training. Percutaneous transluminal atherectomy equipment is expensive, the operation is complex, the operation time is long, and it is difficult to solve the problems of distal embolization and high risk of blood vessel injury. To solve the problems in the treatment of calcified blood vessels above, by combining ultrasonic lithotripsy and balloon angioplasty technology, and treating calcified arterial diseases by using shock waves, it can better overcome the deficiencies of traditional equipment and technology in the treatment process. Therefore, the shock wave balloon is expected to become a new generation of calcified vascular treatment technology. The traditional shock wave balloon has the following problems: the electrode is exposed outside the balloon, and it is easy to damage the balloon material when releasing heat, and adverse events such as in vivo balloon rupture are likely to occur; it does not have a protection umbrella system, and the calcium compounds removed are easy to flow with the blood and are easy to form thrombus; it cannot inhibit tissue hyperplasia, and it is easy to cause many complications such as restenosis of blood vessels. Summary of the Invention

[0004] Based on this, it is necessary to provide a shock wave drug balloon catheter device to address the problems of easy damage to the balloon material, inability to inhibit tissue hyperplasia, and the calcium compounds removed being easy to flow with the blood and form thrombus existing in the traditional shock wave balloon.

[0005] A shock wave drug balloon catheter device includes: a drug balloon catheter assembly;

[0006] The drug balloon catheter assembly includes a catheter body, an ultrasonic transducer, and a balloon component located at the distal end of the catheter body and connected to the catheter body;

[0007] The balloon component has a balloon cavity, and the balloon cavity has a first filling state when partially filled and a second filling state when completely filled. When the balloon cavity is in the first filling state, it is used to fill the medium for shock wave treatment of vascular calcification plaques and for squeezing calcified plaques. When the balloon cavity is in the second filling state, it is used to fill the medium for drug treatment of the blood vessel wall through the drug coated on the balloon cavity;

[0008] The electrode end of the ultrasonic transducer extends into the balloon cavity, and the control end of the ultrasonic transducer is located at the proximal end of the catheter body.

[0009] In some embodiments, the balloon component has a plurality of folding wings, and an anti-cell proliferation drug layer or a thrombolytic, anti-inflammatory and anticoagulant drug layer is coated on the folding wings. When the balloon cavity is completely filled, the folding wings can be filled and unfolded outward to form the second filled state.

[0010] In some embodiments, the electrode end has a plurality of ultrasonic imaging positions, and the ultrasonic imaging positions are distributed on one side of the electrode end facing the distal end of the electrode end and one side of the proximal end of the electrode end.

[0011] In some embodiments, the balloon component is a non-compliant balloon or a semi-compliant balloon.

[0012] In some embodiments, the catheter body has a guide wire cavity, a first filling channel and a second filling channel, and both the first filling channel and the second filling channel are communicated with the balloon cavity.

[0013] In some embodiments, the catheter body is a coaxial catheter. The proximal end of the catheter body has a guide wire cavity joint communicated with the guide wire cavity, a first filling joint communicated with the first filling channel, and a second filling joint communicated with the second filling channel;

[0014] Alternatively, the catheter body is an exchange catheter. The catheter body includes an outer tube and an inner tube. The outer tube has the first filling channel and the second filling channel. The distal end of the outer tube is connected to the balloon component. The proximal end of the outer tube has a third filling joint communicated with the first filling channel and a fourth filling joint communicated with the second filling channel. The inner tube is disposed through the outer tube and passes out from the outer wall of the proximal end of the outer tube. The inner tube has the guide wire cavity.

[0015] In some embodiments, a guide wire assembly is further included. The guide wire assembly includes a guide wire rod, an elastic protective umbrella located at the distal end of the guide wire rod, and a guide wire head. Guide wire imaging positions are provided at positions on the guide wire rod at both ends of the protective umbrella.

[0016] In some embodiments, the guide wire head is elastic, the distal end of the guide wire rod has a conical structure, and the guide wire head is sleeved on the distal end of the guide wire rod.

[0017] In some embodiments, the protective umbrella is a mesh structure made of nitinol alloy after being woven and heat-treated or after being cut, pickled, polished and heat-treated.

[0018] In some of these embodiments, the surface of the protective umbrella is coated with a polymer film layer, and the material of the polymer film layer is selected from polyurethane or polytetrafluoroethylene.

[0019] In some of these embodiments, the wire visualization positions on the guide wire rod at both ends of the protective umbrella are both adjacent to the protective umbrella.

[0020] In some of these embodiments, a delivery catheter assembly is further included, and the delivery catheter assembly includes a first catheter channel for the wire assembly to pass through and a second catheter channel for the drug balloon catheter assembly to pass through.

[0021] In some of these embodiments, a retrieval catheter is further included, and the retrieval catheter is used to retrieve the protective umbrella after the treatment is completed and the drug balloon catheter assembly is retracted, for the delivery catheter assembly to pass through.

[0022] The balloon in the above shock wave drug balloon catheter device has a high service life, the calcified substances removed by the ultrasonic shock wave can be effectively retrieved, will not form thrombus with the blood flow, can effectively inhibit tissue hyperplasia, and reduce many complications such as vascular restenosis.

[0023] In summary, the above shock wave drug balloon catheter device has the following beneficial effects:

[0024] (1) The present invention can effectively treat vascular calcification deposits and can effectively solve symptoms such as peripheral arterial vascular calcified plaques.

[0025] (2) The folding wings of the balloon component in the present invention are sprayed with an anti-cell proliferation drug (such as one or several combinations of rapamycin-like mTOR inhibitors or paclitaxel, etc.) or a thrombolytic, anti-inflammatory and anticoagulant drug, which can inhibit tissue hyperplasia.

[0026] (3) The present invention includes a wire assembly with a protective umbrella, which can effectively collect the removed calcified substances, prevent the calcified substances from flowing with the blood, and prevent thrombus formation. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following will briefly introduce the drawings required for the description of the embodiments. Obviously, the following drawings are only some embodiments of the present application, and those skilled in the art can obtain other drawings according to these drawings without creative efforts.

[0028] In order to more completely understand the present application and its beneficial effects, the following will be described in conjunction with the drawings. Among them, the same reference numerals in the following description represent the same parts.

[0029] Figure 1 Schematic diagram of the guide wire assembly of the shock wave drug balloon catheter device according to an embodiment of the present invention;

[0030] Figure 2 Schematic diagram of the drug balloon catheter assembly of the shock wave drug balloon catheter device according to an embodiment of the present invention;

[0031] Figure 3 Schematic diagram of the drug balloon catheter assembly of the shock wave drug balloon catheter device according to an embodiment of the present invention;

[0032] Figure 4 Schematic diagram of the balloon component of the drug balloon catheter assembly according to an embodiment of the present invention;

[0033] Figure 5 Schematic diagram of the folded state of the folding wings of the drug balloon catheter assembly according to an embodiment of the present invention;

[0034] Figure 6 is Figure 5 Schematic diagram of the state when the balloon component shown is partially inflated;

[0035] Figure 7 is Figure 5 Schematic diagram of the state when the balloon component shown is fully inflated;

[0036] Figure 8 Schematic cross-sectional view of the shock wave drug balloon catheter body according to an embodiment of the present invention;

[0037] Figure 9 Schematic diagram of the delivery catheter assembly of the shock wave drug balloon catheter device according to an embodiment of the present invention;

[0038] Figure 10 Schematic diagram of the recovery catheter of the shock wave drug balloon catheter device according to an embodiment of the present invention.

[0039] Description of reference numerals

[0040] 10. Guide wire assembly; 101. Guide wire rod; 1011. Guide wire visualization position; 102. Protective umbrella; 103. Guide wire head; 104. Polymer thin film layer;

[0041] 20. Drug balloon catheter assembly; 201. Catheter body; 201a. Outer tube; 201b. Inner tube; 2011. Guide wire lumen; 2012. First inflation channel; 2013. Second inflation channel; 2014. Guide wire lumen connector; 2015. First inflation connector; 2016. Second inflation connector; 2017. Third inflation connector; 2018. Fourth inflation connector; 202. Ultrasonic transducer; 2021. Electrode end; 20211. Ultrasonic imaging position; 2022. Control end; 203. Balloon component; 2031. Folding wing;

[0042] 30. Delivery catheter assembly; 301. First catheter channel; 302. Second catheter channel;

[0043] 40. Retrieval catheter. Detailed implementation manners

[0044] To make the above objects, features, and advantages of the present invention more obvious and understandable, the following describes the detailed implementation manners of the present invention with reference to the accompanying drawings. Many specific details are set forth in the following description to fully understand the present invention. However, the present invention can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the connotation of the present invention. Therefore, the present invention is not limited by the specific embodiments disclosed below.

[0045] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation of the present invention.

[0046] In addition, the terms "first" and "second" are only used for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Thus, the features defined with "first" and "second" may explicitly or implicitly include at least one of such features. In the description of the present invention, "a plurality" means at least two, such as two, three, etc., unless otherwise specifically defined.

[0047] In the present invention, unless otherwise clearly defined or limited, terms such as "installed", "connected", "linked", "fixed", etc. shall be understood in a broad sense. For example, it may be a fixed connection, a detachable connection, or integrated; it may be a mechanical connection or an electrical connection; it may be directly connected or indirectly connected through an intermediate medium, and it may be the internal communication of two components or the interaction relationship between two components, unless otherwise clearly defined. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0048] In the present invention, unless otherwise clearly defined or limited, the first feature being "on" or "under" the second feature may be that the first and second features are in direct contact, or the first and second features are indirectly in contact through an intermediate medium. Moreover, the first feature being "above", "over" and "on top of" the second feature may mean that the first feature is directly above or obliquely above the second feature, or merely indicates that the first feature is at a higher horizontal level than the second feature. The first feature being "under", "beneath" and "underneath" the second feature may be that the first feature is directly below or obliquely below the second feature, or merely indicates that the first feature is at a lower horizontal level than the second feature.

[0049] It should be noted that when an element is referred to as "fixed to" or "disposed on" another element, it can be directly on the other element or there may also be an intermediate element. When an element is considered to be "connected" to another element, it can be directly connected to the other element or there may be an intermediate element at the same time. The terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used herein are only for the purpose of illustration and do not represent the only implementation.

[0050] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the technical field to which this invention belongs. The terms used herein in the description of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention. The term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0051] It should be noted that in the following description, "proximal" generally refers to the end closer to the doctor during normal operation, and correspondingly, "distal" generally refers to the end farther from the doctor during normal operation.

[0052] The embodiments of the present application provide a shock wave drug balloon catheter device to solve the problems existing in traditional shock wave balloons, such as easy damage to the balloon material, inability to inhibit tissue hyperplasia, and the calcified substances removed are easily carried by the blood flow and prone to form thrombus. The following will be described with reference to the accompanying drawings.

[0053] The shock wave drug balloon catheter device provided by the embodiments of the present application. Exemplarily, the shock wave drug balloon catheter device of the present application can be used to treat calcified arterial diseases and can better overcome the deficiencies of traditional devices and technologies during the treatment process.

[0054] To more clearly illustrate the structure of the shock wave drug balloon catheter device, the shock wave drug balloon catheter device will be introduced below in conjunction with the accompanying drawings.

[0055] Exemplarily, a shock wave drug balloon catheter device includes a guide wire assembly 10, a drug balloon catheter assembly 20, a delivery catheter assembly 30, and a retrieval catheter 40.

[0056] It should be noted that the guide wire assembly 10, the delivery catheter assembly 30, and the retrieval catheter 40 in the shock wave drug balloon catheter device can all be used as accessories. The following technical solutions are described in detail and specifically as a whole for the guide wire assembly 10, the drug balloon catheter assembly 20, the delivery catheter assembly 30, and the retrieval catheter 40, but should not be construed as a limitation to the scope of the present invention patent.

[0057] Please refer to Figure 1 as shown in Figure 1 FIG. 16 is a schematic diagram of the guide wire assembly 10 of the shock wave drug balloon catheter device according to an embodiment of the present invention. The guide wire assembly 10 includes a guide wire rod 101, an elastic protective umbrella 102 located at the distal end of the guide wire rod 101, and a guide wire head 103. Guide wire imaging positions 1011 are provided at both ends of the guide wire rod 101 where the protective umbrella 102 is located.

[0058] Please refer to Figure 2 and Figure 3 as shown in Figure 2 FIG. 25 is a schematic diagram of the drug balloon catheter assembly 20 of the shock wave drug balloon catheter device according to an embodiment of the present invention, Figure 3 FIG. 27 is a schematic diagram of the drug balloon catheter assembly 20 of the shock wave drug balloon catheter device according to another embodiment of the present invention; the drug balloon catheter assembly 20 includes a catheter body 201, an ultrasonic transducer 202, and a balloon component 203 located at the distal end of the catheter body 201 and connected to the catheter body 201.

[0059] Please refer to Figure 4 as shown in Figure 4 FIG. 34 is a schematic diagram of the balloon component 203 of the drug balloon catheter assembly 20 according to an embodiment of the present invention; the balloon component 203 has a balloon cavity, and the balloon cavity has a first filling state when partially filled (see Figure 6 as shown in Figure 6 FIG. 44 is a schematic diagram of the state of the balloon component 203 when partially filled) and a second filling state when fully filled (see Figure 7 as shown in Figure 7Schematic diagram of the state when the balloon component 203 is fully inflated. When the balloon cavity is in the first inflation state, it is used to fill the medium for shock wave treatment of vascular calcified plaques and for squeezing the calcified plaques (the dropped calcified plaques are collected by the protection umbrella). When the balloon cavity is in the second inflation state, it is used to fill the medium for drug treatment and loosening of calcium deposits.

[0060] Please refer to Figure 8 as shown Figure 8 Schematic cross-sectional view of the shock wave drug balloon catheter body 201 according to an embodiment of the present invention. The catheter body 201 has a guide wire cavity 2011, a first inflation channel 2012, and a second inflation channel 2013. Figure 8 Shows a radial cross-sectional view of the proximal end of the catheter body 201.

[0061] The electrode end 2021 of the ultrasonic transducer 202 extends into the balloon cavity. The control end 2022 of the ultrasonic transducer 202 is located at the proximal end of the catheter body 201. Among them, the control end 2022 is located on the outer wall of the catheter body 201, the electrode end 2021 is distributed along the tube axis, the electrode end 2021 has multiple arrays, and ultrasonic transducers are arranged on each array. Among them, the wire for supplying power to the multiple ultrasonic transducers on the electrode end 2021 extends along the inner cavity of the catheter body 201 to the control end 2022 at the proximal end of the catheter body 201, and the power interface on the control end 2022 is used in matching with the power supply device.

[0062] Both the first inflation channel 2012 and the second inflation channel 2013 are communicated with the balloon cavity. Among them, the first inflation channel 2012 is used to input the inflation medium into the balloon cavity for shock wave treatment of peripheral arterial vascular calcified plaques, and the second inflation channel 2013 is used to input the inflation medium into the balloon cavity for drug treatment and loosening of calcium deposits.

[0063] Please refer to Figure 9 as shown Figure 9 Schematic diagram of the delivery catheter assembly 30 of the shock wave drug balloon catheter device according to an embodiment of the present invention. The delivery catheter assembly 30 includes a first catheter channel 301 for the guide wire assembly 10 to pass through and a second catheter channel 302 for the drug balloon catheter assembly 20 to pass through. The first catheter channel 301 and the second catheter channel 302 are arranged in parallel and are independent of each other.

[0064] Please refer to Figure 10 as shown Figure 10 Schematic diagram of the recovery catheter 40 of the shock wave drug balloon catheter device according to an embodiment of the present invention. The recovery catheter 40 is used for the delivery catheter assembly 30 to pass through, and the recovery catheter 40 is used to recover the protection umbrella 102 after the treatment is completed and the drug balloon catheter assembly 20 is retracted.

[0065] The above-mentioned shock wave drug balloon catheter device has a high balloon service life. The calcium deposits removed by the ultrasonic shock wave can be effectively recovered and will not form thrombus with the blood flow. It can effectively inhibit tissue hyperplasia and reduce many complications such as vascular restenosis.

[0066] The working principle of the above-mentioned shock wave drug balloon catheter device is as follows: The guide wire rod 101 with the protection umbrella 102 reaches a certain position at the distal end of the target lesion through the delivery catheter assembly 30. The delivery catheter assembly 30 is retracted a certain distance, and the distal protection umbrella 102 is released; the drug balloon catheter assembly 20 is used for treatment; after the treatment is completed, the drug balloon catheter assembly 20 is first retracted, and then the recovery catheter 40 is pushed forward to the distal end until the distal end of the recovery catheter 40 completely covers the distal protection umbrella 102, and then the guide wire assembly 10, the recovery catheter 40 and the contents are retracted together. When the catheter body 201 is a coaxial catheter (OTW), the guide wire rod 101 with the protection umbrella 102 can also be directly inserted into the guiding catheter to reach a certain position at the distal end of the target lesion. The guiding catheter is retracted a certain distance, and the distal protection umbrella 102 is released; the drug balloon catheter assembly 20 is used for treatment; after the treatment is completed, the drug balloon catheter assembly 20 is first retracted, and then the recovery catheter 40 is pushed forward to the distal end until the distal end of the recovery catheter 40 completely covers the distal protection umbrella 102, and then the guide wire assembly 10, the recovery catheter 40 and the contents are retracted together.

[0067] In some embodiments, the above ultrasonic transducer is a capacitive micromachined ultrasonic transducer 202.

[0068] In some embodiments, the protection umbrella 102 is fixedly connected to the guide wire rod 101. For example, the protection umbrella 102 is connected to the guide wire rod 101 by welding, so as to limit the sliding of the distal protection umbrella 102 on the guide wire rod 101. It is not difficult to understand that in other embodiments, the protection umbrella 102 and the guide wire rod 101 can also be connected by other means.

[0069] In some embodiments, please refer to Figure 1 As shown, the guide wire head 103 has elasticity. The distal end of the guide wire rod 101 is in a conical structure, and the guide wire head 103 is sleeved on the distal end of the guide wire rod 101.

[0070] In some embodiments, the guide wire head 103 is made of platinum or an alloy of platinum. The guide wire head 103 is relatively soft. The soft and elastic guide wire head 103 can prevent damage to the blood vessel and has good flexibility, so that it can better enter the curved blood vessel.

[0071] In some embodiments, the material of the guide wire rod 101 is nitinol or stainless steel.

[0072] In some of these embodiments, the umbrella protector 102 is a net structure made of a nickel-titanium alloy that is heat-treated after being woven or made by cutting, pickling, polishing, and heat-treating.

[0073] In some of these embodiments, the surface of the umbrella protector 102 is coated with a polymer thin film layer 104. The polymer thin film layer 104 can ensure the interception effectiveness of calcified plaques.

[0074] In some of these embodiments, the material of the polymer thin film layer 104 is selected from polyurethane or polytetrafluoroethylene.

[0075] In some of these embodiments, at the positions of both ends of the umbrella protector 102 on the guide wire screw rod 101, the guide wire visualization positions 1011 are both adjacent to the umbrella protector 102. The material of the visualization points provided on the guide wire visualization positions 1011 can be gold, platinum, or an alloy of platinum, etc. The visualization points on the guide wire visualization positions 1011 are used to improve the accuracy of intraoperative positioning.

[0076] In some of these embodiments, please refer to Figure 4 , Figure 5 as shown, Figure 5 is a schematic diagram of the folding wings 2031 of the drug balloon catheter assembly 20 according to an embodiment of the present invention; the balloon component 203 has a plurality of folding wings 2031. When the balloon component 203 is fully inflated, the folding wings 2031 can be fully unfolded and form the above-mentioned second inflated state. Figure 5 Three folding wings 2031 are shown in

[0077] In some of these embodiments, the folding wings 2031 are coated with an anti-cell proliferation drug layer or a thrombolytic, anti-inflammatory, and anticoagulant drug layer. The anti-cell proliferation drug layer contains one or several of rapamycin-like mTOR inhibitors or paclitaxel. The drug dosage form in the above anti-cell proliferation drug layer or thrombolytic, anti-inflammatory, and anticoagulant drug layer can adopt nano-formulations, rapid-release formulations, etc.

[0078] In some of these embodiments, please refer to Figure 4As shown, the electrode tip 2021 has a plurality of ultrasonic imaging positions 20211. The distal end of the electrode tip 2021 and the relative position away from the distal end of the electrode tip 2021 (towards the proximal end of the electrode tip 2021) are respectively provided with ultrasonic imaging positions 20211, that is, the side of the electrode tip 2021 facing the distal end and the side facing the proximal end are respectively provided with ultrasonic imaging positions 20211. Imaging points are provided on the ultrasonic imaging positions 20211. The ultrasonic imaging positions 20211 are symmetrically arranged on the electrode tip 2021. The material of the imaging points provided on the ultrasonic imaging positions 20211 can be gold, platinum or an alloy of platinum, etc. The imaging points on the ultrasonic imaging positions 20211 are used to improve the accuracy of intraoperative positioning.

[0079] In some embodiments, the balloon component 203 is a non-compliant balloon or a semi-compliant balloon. Further, the balloon component 203 can be made of a polymer material such as Pebax, nylon or a hybrid material.

[0080] In some embodiments, when the catheter body 201 is a coaxial catheter (OTW), please refer to Figure 2 As shown, the proximal end of the catheter body 201 has a guide wire connector 2014 communicating with the guide wire lumen 2011, a first filling connector 2015 communicating with the first filling channel 2012, and a second filling connector 2016 communicating with the second filling channel 2013.

[0081] Or, in another embodiment, when the catheter body 201 is an exchange catheter (REX), please refer to Figure 3 As shown, the catheter body 201 includes an outer tube 201a and an inner tube 201b. The outer tube 201a has a first filling channel 2012 and a second filling channel 2013. The distal end of the outer tube 201a is connected to the balloon component 203. The proximal end of the outer tube 201a has a third filling connector 2017 communicating with the first filling channel 2012 and a fourth filling connector 2018 communicating with the second filling channel 2013. The inner tube 201b is inserted through the outer tube 201a and passes out of the outer wall of the proximal end of the outer tube 201a. The inner tube 201b has a guide wire lumen 2011.

[0082] The above shock wave drug balloon catheter device is operated by the doctor during the operation according to the following steps:

[0083] First, insert the outer guiding catheter into the opening of the target blood vessel to reach the predetermined position, perform angiography, and select the corresponding size of the guide wire assembly 10, the delivery catheter assembly 30, and the drug balloon catheter assembly 20 according to the diameter of the blood vessel. It should be noted that the outer guiding catheter is the outermost catheter and enters the blood vessel first. The outer guiding catheter is an accessory in the conventional operation and is not shown in the drawings.

[0084] Insert the proximal end of the guide wire assembly 10 into the first catheter channel 301 at the distal end of the delivery catheter assembly 30. Then, push the guide wire rod 101 of the guide wire assembly 10 forward so that the distal umbrella protection device 102 is completely fed into the delivery catheter assembly 30. Next, take the guide wire assembly 10 and the delivery catheter assembly 30 as a whole and insert them into the outer guiding catheter, and push them to the target position. Then, retract a part of the delivery catheter assembly 30 towards the proximal end to mechanically open the distal umbrella protection device 102. During treatment, insert the guiding wire through another channel of the delivery catheter assembly 30, that is, the second catheter channel 302, to the target position. Push the drug balloon catheter assembly 20 through the guiding wire to the lesion site.

[0085] When the catheter body 201 is a coaxial catheter (OTW), the guide wire assembly 10 can also be directly inserted into the guiding catheter. Push the guide wire rod 101 of the guide wire assembly 10 forward so that the distal umbrella protection device 102 is completely fed into the guiding catheter. Continue to push the guide wire assembly 10 to the target position. Then, retract a part of the guiding catheter towards the proximal end to mechanically open the distal umbrella protection device 102. Considering that the guide wire assembly 10 already has radiopacity, during treatment, the guide wire assembly 10 can be directly used as the guiding wire and slide rail, and the drug balloon catheter assembly 20 is pushed through the guide wire assembly 10 to the lesion site.

[0086] When using the drug balloon catheter assembly, first fill the balloon cavity of the balloon component 203 with contrast medium through the first filling channel 2012, control the control end 2022 of the ultrasonic transducer 202 to turn on the ultrasound, and perform shock wave treatment on the calcified plaque; then retract all or part of the contrast medium, and then fill the balloon cavity of the balloon component 203 with contrast medium through the second filling channel 2013. After filling through the multiple folding wings 2031, loosen the calcified plaque, and at the same time release the drugs coated on the balloon component 203 and its folding wings 2031 for drug treatment. After the treatment is completed and the drug balloon catheter assembly 20 is retracted, sleeve the recovery catheter 40 on the outer layer of the delivery catheter assembly 30 and push it forward towards the distal umbrella protection device 102 until the distal end of the recovery catheter 40 completely covers the distal umbrella protection device 102, and then retract the recovery catheter 40 and its contents together.

[0087] The specific steps of the preparation method of some structures of the above shock wave drug balloon catheter device are as follows:

[0088] (1) The nickel-titanium alloy is made into the umbrella protection device 102 after braiding and heat treatment or after cutting, pickling, polishing, and heat treatment. A polymer film layer 104 can be added to the umbrella protection device 102 to form a polymer thin film layer, and then the umbrella protection device 102 is fixed to the guide wire.

[0089] (2) Assemble the umbrella protection device 102 with the delivery catheter assembly 30, the recovery catheter 40, etc., and make it ready for use after necessary processes such as packaging and sterilization.

[0090] The specific steps of the preparation method of the drug balloon catheter assembly 20 are as follows:

[0091] (1) Pass the copper wire through the tube wall from the lumen of the catheter body 201 and connect it to the control end 2022 of the ultrasonic transducer 202. The electrode end 2021 of the ultrasonic transducer 202 is fixed to the lumen of the catheter body 201 by adhesion or welding.

[0092] (2) When the catheter body 201 is a replaceable catheter (REX), first prepare the balloon component 203, weld and assemble the balloon component 203, the electrode end 2021, etc., make a guide wire port on the balloon component 203, then spray the drug preparation on the surface of the balloon component 203, and synchronously manufacture the catheter body 201 (such as the inner tube 201b and the outer tube 201a) and then assemble; when the catheter body 201 is a coaxial catheter (OTW), first prepare the catheter body 201, weld and assemble each component such as the balloon component 203, and then spray the drug preparation on the surface of the balloon component 203.

[0093] (3) After the folding wings 2031 on the balloon component 203 are folded, they are ready for use after necessary processes such as packaging and sterilization.

[0094] In summary, the above shock wave drug balloon catheter device has the following beneficial effects:

[0095] (1) The present invention can effectively treat vascular calcification deposits and can effectively solve symptoms such as peripheral arterial vascular calcified plaques.

[0096] (2) The folding wings 2031 of the balloon component 203 of the present invention are sprayed with anti-proliferative drugs (such as one or several combinations of rapamycin-like mTOR inhibitors or paclitaxel, etc.) or thrombolytic, anti-inflammatory and anticoagulant drugs, which can inhibit tissue hyperplasia.

[0097] (3) The present invention contains a guide wire assembly 10 with a protective umbrella 102, which can effectively collect the calcified substances after cleaning, prevent the calcified substances from flowing with the blood, and prevent the formation of thrombus.

[0098] In the above embodiments, the descriptions of each embodiment have their own emphases. For the parts not detailed in a certain embodiment, reference can be made to the relevant descriptions of other embodiments.

[0099] The technical features of the above embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above embodiments are described. However, as long as the combinations of these technical features do not conflict, they should be considered as the scope recorded in this specification.

[0100] The above-described embodiments merely represent several implementation manners of the present invention. The description thereof is relatively specific and detailed, but it should not be construed as a limitation on the scope of the patent for the present invention. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can still be made, and these all fall within the protection scope of the present invention. Therefore, the protection scope of the patent for the present invention shall be subject to the appended claims.

Claims

1. A shock wave drug balloon catheter device, characterized in that, it includes: a drug balloon catheter assembly; The drug balloon catheter assembly includes a catheter body, an ultrasonic transducer, and a balloon component located at the distal end of the catheter body and connected to the catheter body; The balloon component has a balloon cavity, and the balloon cavity has a first filling state when partially filled and a second filling state when fully filled. When the balloon cavity is in the first filling state, it is used to fill the medium for shock wave treatment of vascular calcified plaques and for squeezing calcified plaques. When the balloon cavity is in the second filling state, it is used to fill the medium for drug treatment of the vascular wall through the drug coated on the balloon cavity; The electrode end of the ultrasonic transducer extends into the balloon cavity, and the control end of the ultrasonic transducer is located at the proximal end of the catheter body.

2. The shock wave drug balloon catheter device according to claim 1, characterized in that, The balloon component has a plurality of folding wings, and an anti-proliferative drug layer or a thrombolytic, anti-inflammatory, and anticoagulant drug layer is coated on the folding wings. When the balloon cavity is fully filled, the folding wings can be filled and expand outwards to form the second filling state.

3. The shock wave drug balloon catheter device according to any one of claims 1-2, characterized in that, The catheter body has a guide wire cavity, a first filling channel, and a second filling channel, and both the first filling channel and the second filling channel are communicated with the balloon cavity.

4. The shock wave drug balloon catheter device according to claim 3, characterized in that, The catheter body is a coaxial catheter. The proximal end of the catheter body has a guide wire cavity connector communicated with the guide wire cavity, a first filling connector communicated with the first filling channel, and a second filling connector communicated with the second filling channel; Alternatively, the catheter body is an exchangeable catheter. The catheter body includes an outer tube and an inner tube. The outer tube has the first filling channel and the second filling channel. The distal end of the outer tube is connected to the balloon component. The proximal end of the outer tube has a third filling connector communicated with the first filling channel and a fourth filling connector communicated with the second filling channel. The inner tube is inserted through the outer tube and passes out from the outer wall of the proximal end of the outer tube. The inner tube has the guide wire cavity.

5. The shock wave drug balloon catheter device according to any one of claims 1-2, 4, characterized in that, It further includes a guide wire assembly. The guide wire assembly includes a guide wire rod, an elastic protective umbrella located at the distal end of the guide wire rod, and a guide wire head. Guide wire imaging positions are provided at both ends of the guide wire rod where the protective umbrella is located.

6. The shock wave drug balloon catheter device according to claim 5, characterized in that, The guide wire head is elastic. The distal end of the guide wire rod has a conical structure, and the guide wire head is sleeved on the distal end of the guide wire rod.

7. The shock wave drug balloon catheter device according to claim 5, characterized in that, The protective umbrella is a mesh structure made of nitinol alloy after being braided and heat-treated or after being cut, pickled, polished, and heat-treated.

8. The shock wave drug balloon catheter device according to claim 5, characterized in that, a polymer film layer is coated on the surface of the protective umbrella, and the material of the polymer film layer is selected from polyurethane or polytetrafluoroethylene.

9. The shock wave drug balloon catheter device according to claim 5, characterized in that, it further includes a delivery catheter assembly, and the delivery catheter assembly includes a first catheter channel for the wire assembly to pass through and a second catheter channel for the drug balloon catheter assembly to pass through.

10. The shock wave drug balloon catheter device according to claim 5, characterized in that, it further includes a recovery catheter, and the recovery catheter is used to recover the protective umbrella after the treatment is completed and the drug balloon catheter assembly is retracted.

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